CurrentBlue Cross Blue Shield - IowaPolicy N/A

MRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation

Policy governing medical coverage and evidence review for MRgFUS procedures (e.g., uterine fibroids, metastatic bone pain palliation, essential tremor, other tumor indications) for Wellmark Blue Cross Blue Shield members; informs provider coverage determinations.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 2007

Next Review DateSeptember 2025

Key ActionDocument medication-refractory status (failure of ≥2 medications) or prior radiotherapy failure/unsuitability when requesting MRgFUS and include required clinical documentation to support indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4FDA indications described

79%Bone mets pooled response

1 RCTET RCTs

2Uterine fibroid RCTs

2011-2025Policy history span

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Coverage Criteria and Evidence-Based Indications

inv-01: Metastatic bone pain — medically necessary — Covered when ALL criteria are met

Covered when ALL criteria are met:

ALL of the following

Patient is an adult with metastatic bone cancer causing focal pain at a target lesion.
Patient has failed prior radiotherapy to the target site, or radiotherapy is contraindicated or not feasible for the target site.
Pain at the target lesion is at least moderate severity (eg, >=4 on a 0-10 numeric rating scale) and is the primary source of the patient’s pain; if multiple lesions exist, the treated lesion must be the worst symptomatic lesion and at least 2 points higher than other lesions on the pain scale.
Target lesion is technically accessible to MRgFUS (device access and anatomy permit safe sonication, per treating specialist assessment).
No reasonable alternative approved palliative local therapy is available or appropriate (eg, patient declines or is not a candidate for further radiotherapy or other interventional palliative procedures).
Documentation in the medical record includes baseline pain score, prior treatments tried (including radiotherapy), rationale for deeming radiotherapy failed or unsuitable, and planned lesion to be treated.

inv-02: Essential tremor — medically necessary — Covered when ALL criteria are met

Covered when ALL criteria are met:

ALL of the following

Diagnosis of medication-refractory essential tremor (ET) with functional impairment attributable to tremor.
Tremor is refractory to or the patient is intolerant of at least two appropriate trials of guideline-directed medical therapy for essential tremor (eg, propranolol, primidone), with documentation of agents tried, doses, durations, and responses or adverse effects.
Patient meets clinical severity thresholds used in pivotal trials (eg, moderate to severe postural or intention tremor of the hand with a score >=2 on the Clinical Rating Scale for Tremor or equivalent), and tremor is the primary cause of functional impairment.
Unilateral MRgFUS thalamotomy is planned (device and anatomy permitting) and patient is a surgical candidate for a unilateral procedure; bilateral thalamotomy approaches are not standard for MRgFUS due to higher risk of adverse effects and are not covered.

inv-03: Investigational / Not Medically Necessary indications — top-level not medically necessary node

MRgFUS is considered investigational / not medically necessary for all indications not meeting the above coverage criteria.

ANY of the following

Any use of MRgFUS for indications other than palliation of metastatic bone pain meeting criteria above or medication-refractory essential tremor meeting criteria above (including but not limited to treatments listed below).
Use of MRgFUS for investigational neurologic indications such as blood–brain barrier disruption for delivery of investigational therapies or for pediatric neuro‑oncology, unless part of a prospective, IRB‑approved clinical trial with appropriate documentation and data collection.

inv-04: Coverage considerations by indication — PICO-focused assessments per indication

Guideline concordance and coverage implications by cancer indication:

ALL of the following

When applicable, national guideline absence of MRgFUS as a recommended treatment option is noted and informs the investigational stance for that cancer indication.
NCCN guidelines currently do not list MRgFUS as a recommended treatment option for multiple cancer indications (including bone cancer, breast cancer, central nervous system cancers, and soft tissue sarcomas/desmoid), which supports classifying MRgFUS for these indications as investigational when not delivered in the context of qualifying clinical trials or explicit local coverage determinations.
For prostate cancer, NCCN notes limited data for focal ablation approaches; MRgFUS is not broadly recommended as routine primary therapy and remains investigational outside of clinical trials or specific evidence-based coverage policies.

inv-05: Study-based coverage context — Bone metastases (trial inclusion/contextual criteria)

Study-based contextual criteria and generalizability considerations for MRgFUS in bone metastases:

ALL of the following

Evidence supporting coverage for painful bone metastases derives from randomized trial populations with specified inclusion criteria (eg, life expectancy >=3 months, single treated lesion that is the primary pain source, lesion accessible to device).
Applicability to real-world patients requires that treated lesions and patient clinical status are similar to those studied; heterogeneity in primary tumor types, short follow-up in many studies, and device access limitations restrict broad generalizability.
Providers should document that the patient meets similar clinical and lesion‑access criteria as the pivotal trials when seeking coverage for MRgFUS for bone pain palliation.

inv-06: Study-based coverage context — Other tumors (nonrandomized trial contexts)

Study-based contextual criteria for nonrandomized tumor indications:

ALL of the following

Evidence for other tumor indications (eg, prostate cancer focal therapy, nonspinal osteoid osteoma) comes primarily from phase II nonrandomized trials and case series; these studies often lack comparators and have limited follow-up.
When MRgFUS is considered for these tumor types in a research or compassionate‑use setting, documentation should include trial protocol identifiers or detailed rationale for use and expected outcomes, and patients should be enrolled in registries or prospective studies when feasible.

inv-07: MRgFUS for Medication-Refractory Essential Tremor — coverage stance reflecting evidence strength

MRgFUS for medication‑refractory essential tremor — evidence‑based coverage stance:

ALL of the following

High‑quality evidence includes a double‑blind, sham‑controlled RCT and supporting meta‑analyses showing significant improvements in tremor severity, function, and quality of life maintained up to 2 years in many patients.
Because bilateral procedures carry higher risk and comparative data show unilateral MRgFUS and unilateral DBS have similar benefits (both inferior to bilateral DBS), coverage is limited to unilateral MRgFUS thalamotomy as specified in the tremor coverage criteria.
Providers should document prior medication trials, clinical severity measures consistent with trial entry criteria, and informed consent discussions summarizing comparative options (including DBS) and potential for diminishing effect over time.

inv-08: MRgFUS for Tumor Indications — variable evidence by tumor type

MRgFUS for tumor indications — evidence limitations and investigational classification:

ALL of the following

For most non‑bone tumor indications, available evidence is limited to small case series, single‑arm phase II trials, or feasibility studies, lacking randomized comparative data and long‑term outcomes necessary to demonstrate net health benefit.
Where promising results exist (eg, focal prostate MRgFUS phase II trials), these are considered preliminary and do not establish routine coverage; use in these contexts should be limited to clinical trials or registries until higher‑level evidence is available.

inv-09: Coverage criteria — MRgFUS for refractory tremor — Covered when ALL criteria are met (evidence from RCTs/systematic reviews)

Coverage criteria — MRgFUS thalamotomy for refractory tremor — operational and evidence notes:

ALL of the following

Coverage limited to unilateral procedures for medication‑refractory essential tremor meeting the criteria in this policy; bilateral MRgFUS thalamotomy is not covered due to increased risk and limited evidence.
Comparative outcomes versus deep brain stimulation (DBS): discuss DBS as an alternative in the informed consent and document why MRgFUS is chosen (eg, patient preference, contraindication to DBS).
Providers should note evidence of diminishing benefit over time in counseling patients and in setting expectations for long‑term outcomes.

inv-10: ACR: Uterine fibroids appropriateness statements

Uterine fibroids — guideline context and coverage considerations:

ALL of the following

Although FDA approval exists for uterine fibroids, randomized trial data and guideline assessments indicate higher reintervention rates and limited long‑term data compared with other uterine‑sparing options; this limits routine coverage for fibroid indications in many clinical scenarios.
ACR appropriateness criteria identify select scenarios where MRgFUS may be usually appropriate or may be appropriate (eg, reproductive‑age patients desiring uterine preservation with limited fibroid burden), but also scenarios where MRgFUS is usually not appropriate (eg, concurrent adenomyosis, postmenopausal patients). Payer coverage will follow the policy’s investigational stance unless specific local coverage rules or additional evidence justify coverage.

inv-11: NCCN: MRgFUS not listed/recommended for multiple cancer indications

NCCN guidance status for cancer indications and policy implication:

ALL of the following

NCCN guidelines for multiple cancer sites (bone cancer, breast cancer, central nervous system cancers including glioblastoma, and soft tissue sarcomas/desmoid tumors) do not currently list MRgFUS as a recommended treatment option.
The absence of MRgFUS in NCCN guidance for these indications supports classifying MRgFUS as investigational for these cancer types outside of prospective clinical trials or explicit coverage policies.

inv-12: Palliative radiation and ablation context (ASTRO/NCCN relevance)

Palliative radiation and ablation context (ASTRO/NCCN relevance):

ALL of the following

ASTRO palliative radiotherapy guidelines emphasize radiotherapy as an effective standard for painful bone metastases and do not currently reference MRgFUS; when MRgFUS is considered, it is typically for patients who have failed or are not candidates for radiotherapy.
Clinical decisions should reference current ASTRO guidance and document rationale when selecting MRgFUS over or after radiotherapy, including discussion of available advanced radiotherapy options (eg, SBRT) when appropriate.

inv-13: Neurology indications (essential tremor) — MR-guided focused ultrasound thalamotomy

Neurology indications (essential tremor) — key references and regulatory context:

ALL of the following

NICE IPG617 and other technology assessments note limited quantity but acceptable safety for unilateral MRgFUS thalamotomy for treatment‑resistant essential tremor, recommending use within governance/audit frameworks or research in some settings.
FDA approval exists for medication‑refractory essential tremor, supporting coverage when policy criteria are met and documentation requirements are satisfied.

Indications Approved or Considered Medically Necessary

Coding, Product, and Regulatory Codes

Prior Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior approval not required in-policy but Category III code use required

Policy lists prior approval as not applicable for this section but requires use of Category III (temporary T) codes when available; coverage still depends on meeting the policy's medically necessary criteria.

Prior Authorization

Prior authorization likely for studied/treated populations

Prior authorization is likely required for requests for MRgFUS when used in the populations described (for example, adults with metastatic bone cancer who have failed or are not candidates for radiotherapy) and for FDA-cleared device indications; check payer processes.

Prior Authorization

Prior authorization must document indication and radiotherapy/trial status

When submitting prior authorization, document the clinical indication and the patient's radiotherapy history or trial-like eligibility (e.g., imaging/biopsy support for tumor ablation cases) to support medical necessity.

Imaging and Contrast Use

Billing Rule

Document MRI guidance and on‑line thermometry during MRgFUS

MRI guidance and on‑line thermometric imaging are integral to MRgFUS procedures and should be documented in procedural records.

Document MRI thermometry and planning images used during the procedure.

Billing Rule

Include pre/post treatment imaging to document lesion and response

Pre‑ and post‑treatment imaging (CT or MRI) were used in studies to document lesion characteristics and response; include such imaging when relevant to support treatment rationale and follow‑up.

Attach imaging demonstrating lesion accessibility and post‑treatment response when applicable.

Not Covered / Investigational Uses

Not covered indications summarized in the policy include: uterine fibroids (in many scenarios), prostate cancer, breast cancer, brain cancer, desmoid tumors, nonspinal osteoid osteoma, medication‑refractory tremor‑dominant Parkinson disease, and investigational neuro‑oncology uses (e.g., temporary BBB disruption). These services may be denied when performed for these investigational indications.

The policy repeats investigational classifications for multiple indications across its inventory; duplicate entries reflect the policy stance that MRgFUS is investigational for various noncovered tumor and neuro‑oncology uses unless explicitly supported by the policy.

Placeholders or duplicate inventory entries in the policy document do not alter coverage determinations; refer to the substantive investigational and medically necessary statements for decision making.

Uses of MRgFUS outside studied indications lack robust randomized comparative evidence; where only observational or small nonrandomized trials exist, these data are insufficient to support coverage as standard therapy and may result in denial.

Additional duplicate or placeholder not‑covered entries in the document emphasize that investigational uses are not supported for routine coverage absent new, high‑quality evidence.

Any remaining duplicate placeholders do not change the policy’s not‑medically‑necessary determinations; rely on explicit criteria and evidence summaries when adjudicating claims.

Background and Technology Overview

Magnetic resonance‑guided focused ultrasound (MRgFUS) is a noninvasive thermoablative technology that combines focused ultrasound energy with MRI guidance and on‑line thermometry to create focal coagulation necrosis in targeted tissue. The technique allows image‑guided targeting and real‑time temperature monitoring during ablation.

Definitions and Key Terms

Definition — MRgFUS (short definition)

Short definitionMRgFUS is a noninvasive treatment that combines focused ultrasound and MRI guidance/thermometry to ablate tissue via thermal coagulation.

Key featuresUses focused ultrasound beams directed to a focal point under MRI guidance to heat tissue and produce coagulation necrosis while sparing surrounding structures.

Imaging roleMRI provides guidance and on-line thermometric imaging for real-time confirmation and adjustment of treatment.

Definition — Category III codes (temporary T codes guidance)

What they areCategory III (temporary T) codes are AMA temporary codes for emerging technologies and allow data collection.

Billing requirementIf a Category III code exists for a procedure, providers must use that code instead of an unlisted or deleted Category I code.

Prior Authorization Guidance

Prior Authorization

Prior approval not applicable here but coverage limited to defined medically necessary criteria

Prior approval is listed as not applicable in this policy section, but coverage is limited to medically necessary criteria; verify payer-specific prior authorization processes before scheduling.

Prior Authorization

Expect prior authorization for non‑FDA or post‑standard‑therapy uses

Prior authorization should be expected for MRgFUS use outside FDA‑approved indications or after failure of standard therapy (for example radiotherapy for bone pain).

Prior Authorization

Prior authorization must document prior radiotherapy failure/unsuitability or trial‑like eligibility

Prior authorization requests should document prior radiotherapy failure/unsuitability or trial‑level eligibility (e.g., device accessibility and NRS thresholds) to align with evidence‑based inclusion criteria.

References, Evidence Summary, and Citations

Key referenced studies and guideline sources summarized in this policy include randomized trials and systematic reviews of MRgFUS for essential tremor and uterine leiomyomata, comparative evidence syntheses (including DBS comparisons for tremor), and multiple professional society guidance documents (ACR, ACOG, NCCN, NICE) that informed the coverage assessments.

Policy Revision History

2025-09Annual review / Policy renewedLatest

Annual review completed and policy renewed (September 2025).

2024-09Annual review / Policy renewed

Annual review completed and policy renewed (September 2024).

2023-09Annual review / Policy renewed

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAugust 2007

Next Review DateSeptember 2025

SourceLink

On This Page

Patient counseling and informed consent documented, including discussion of alternative therapies (including deep brain stimulation), potential benefits, risks, and the likelihood of diminishing effect over time.

Pre-procedure imaging and testing demonstrate target anatomy amenable to MRgFUS and absence of contraindications (eg, implanted ferromagnetic devices incompatible with MRI, bleeding diathesis not correctable).

Prior Authorization

Prior authorization recommended for nonstandard/ investigational indications

Prior authorization is recommended for MRgFUS uses beyond medication‑refractory essential tremor or established tumor indications because evidence is limited; requesters should provide supporting evidence of indication and prior therapies.

Documentation Required

Document medication-refractory status and baseline tremor scores

For essential tremor requests, prior authorization should include documentation that the tremor is medication‑refractory (failed ≥2 adequate medical therapies) and baseline validated tremor scores as used in the RCTs.

Document failure of at least two adequate medications.
Include baseline Clinical Rating Scale for Tremor (hand tremor subscore/CRST) or equivalent validated scores.

Prior Authorization

Prior authorization: document consistency with guidance for specific indications

For indication‑specific MRgFUS (e.g., symptomatic uterine fibroids), prior authorization should demonstrate consistency with cited guidance and device labeling, including fertility/desire status and applicable society recommendations.

For uterine fibroids, document desire for fertility and fibroid characteristics per ACR/ACOG considerations.
Confirm use is consistent with device approvals and guidance referenced in the policy.

Billing Rule

Use listed CPT/Category III codes and check payer prior‑auth rules

Report MRgFUS services using the listed CPT/temporary codes (e.g., 0071T, 0072T, 0947T, 61715) and verify payer-specific prior authorization requirements tied to those codes before submission.

Use available Category III (T) codes instead of unlisted Category I codes when applicable.
Check payer systems for any prior authorization requirements associated with these CPT codes.

Documentation Required

Document failure of or ineligibility for radiotherapy for bone pain

For coverage of metastatic bone pain, the policy requires that patients have failed or be ineligible for radiotherapy; document prior radiotherapy failure, unsuitability, or patient decline.

Document prior external‑beam radiotherapy attempt or the reason radiotherapy is not a candidate.

Step Therapy

Step therapy: MRgFUS after radiotherapy failure or unsuitability

MRgFUS for metastatic bone pain is positioned as an option after radiotherapy failure or when radiotherapy is unsuitable; consider supportive care as the primary comparator in documentation.

Ensure records show conservative/supportive measures and radiotherapy were tried or documented as unsuitable.

Documentation Required

Document prior conservative care and radiotherapy attempt or unsuitability

When requesting MRgFUS, include documentation of conservative/supportive care and either an attempt at radiotherapy or a documented reason radiotherapy is unsuitable to meet the step‑therapy context for bone metastases.

Record prior analgesic/regimen trials and objective evidence of inadequate pain control (e.g., NRS).
Document rationale if radiotherapy was not attempted.

Prior Authorization

Prior authorization: document trial of ≥2 medications for ET

For essential tremor, prior authorization and records must show trials of at least two adequate medical therapies have failed before MRgFUS is considered.

List prior medications tried, duration, and reason for discontinuation or inadequate response (failure of ≥2 medications).

Step Therapy

Medication‑refractory ET requirement: failure of ≥2 meds must be documented

The policy and trials require failure of ≥2 medications for essential tremor, implying stepwise medical therapy must be documented prior to MRgFUS consideration.

Provide medication history showing at least two adequate trials without sufficient benefit.

Note

Document consideration of alternatives per ACOG for fibroid patients

When considering MRgFUS for uterine fibroids, providers should document alternatives per ACOG (e.g., uterine artery embolization, myomectomy) because comparative data suggest different symptom and reintervention profiles.

Document discussion of alternatives and comparative outcomes when applicable.

Billing Rule

Use Category III codes when available; do not use unlisted codes

If a Category III (temporary T) code exists for the procedure, use the Category III code rather than an unlisted or deleted Category I code; Category III codes may still be considered investigational unless policy explicitly covers them.

Use Category III codes where available to report MRgFUS procedures.

Documentation Required

Required clinical documentation: indication, prior therapies, device eligibility

Required clinical documentation should include the indication, prior therapies (for example prior radiotherapy for bone metastases), patient eligibility consistent with device approvals, and supporting clinical data referenced in the policy.

Indication and relevant staging/diagnostic data (imaging/biopsy as appropriate).
Prior therapies and their outcomes (e.g., radiotherapy details).
Patient age and device labeling criteria when applicable (e.g., age ≥22 for ExAblate Neuro).

Documentation Required

Suggested documentation: pain severity, radiotherapy status, lesion accessibility

Suggested documentation to support medical necessity includes baseline pain severity (NRS), radiotherapy status or unsuitability, and description of the lesion targeted and its accessibility to the device.

Baseline Numeric Rating Scale (NRS) pain score and change over time.
Evidence of lesion accessibility on imaging and life‑expectancy considerations.

Documentation Required

Document required clinical outcomes (biopsy/pathology, tremor scores, QoL)

Document clinical outcomes in follow‑up records as appropriate to the indication (e.g., biopsy/pathology for prostate at 6 months; standardized tremor scores and quality‑of‑life measures for ET).

6‑month biopsy results for prostate focal ablation when performed.
Follow‑up CRST/hand tremor subscores and QoL measures for ET.

Documentation Required

Include trial‑style baseline and 3‑month outcome measures and adverse events

Trials reported baseline and 3‑month outcome measures (hand tremor subscore, CRST) and adverse events; prior medication history (failed ≥2 medications) should be documented in records submitted for ET.

Include baseline and 3‑month CRST or hand tremor subscores.
Report adverse events and prior medication trials.

Documentation Required

Document indication and fertility status for uterine fibroid requests

For uterine fibroid cases, document clinical indication, desire for future fertility, and fibroid characteristics (for example pedunculated submucosal or number/volume per ACR guidance) when submitting requests.

Document symptom status and fertility desires.
Provide fibroid count, size, and location (pedunculated/submucosal) as applicable.

Billing Rule

Use appropriate billing codes and refer to policy contact for new information

Use the appropriate CPT/HCPCS/ICD codes listed in the policy when submitting claims and refer to the policy history or Wellmark Medical Policy Analyst contact information for submitting new information.

Ensure claims use the listed CPT codes (0071T, 0072T, 0947T, 61715) where applicable.
Contact Wellmark Medical Policy Analyst for new evidence or queries per policy history.

Denial Risk

Investigational indications (not covered) may be denied

MRgFUS for indications considered investigational (including uterine fibroids, prostate cancer, breast cancer, brain cancer, desmoid tumors, non‑spinal osteoid osteoma, and tremor‑dominant PD) is not covered; services for these indications may be denied.

Denial Risk

Non‑FDA‑approved/regulatory indications risk denial

Use of MRgFUS for non–FDA‑approved applications (for example temporary BBB disruption or pediatric neuro‑oncology) lacks regulatory approval and may be denied or considered investigational.

Denial Risk

Eligibility requirements (device access, life expectancy, NRS thresholds) — denial risk if unmet

Eligibility requirements from trials (device‑accessible target, life expectancy ≥3 months, and minimum pain thresholds such as NRS ≥4) must be met; inability to meet these inclusion criteria may result in denial.

Document NRS pain ≥4 where applicable and demonstrate target lesion accessibility.
Document life expectancy and device suitability.

Denial Risk

Evidence insufficiency for many tumor indications may lead to denial

Lack of randomized comparative evidence for many tumor indications (small case series only) may lead to denial for non‑supported tumor uses.

Denial Risk

Study limitations (small size, limited follow‑up, crossover) may affect coverage

Study conduct limitations—small trial sizes, limited follow‑up, crossover, and subsequent DBS after MRgFUS—are noted and could affect coverage decisions for investigational indications.

Denial Risk

ACR 'Usually not appropriate' — adenomyosis scenario may be denied

ACR rates MRgFUS as 'Usually not appropriate' for reproductive‑age patients with fibroids and concurrent adenomyosis; providing MRgFUS in that scenario could trigger denial based on appropriateness guidance.

Billing Rule

Use appropriate codes for claims to avoid denial

Claims must use appropriate CPT, HCPCS, Revenue, and ICD diagnosis codes when reporting provider services; incorrect or inappropriate coding may result in claim denial.

Verify use of Category III codes where available and the specific CPT codes listed in the policy.

Billing Rule

Document MRI planning and contrast use per procedure workflow

Procedure‑specific MRI planning and contrast use (for example, contrast imaging for breast ablation workflows) are noted in study protocols and should be included in documentation when applicable.

Document contrast‑enhanced MRI planning parameters when used for the intended procedure.

Billing Rule

Ensure MRI thermometry and procedural imaging documented

MRI thermometry and procedural imaging are part of MRgFUS technique and should be evidenced in operative notes and imaging records.

Coverage implicationServices represented by Category III codes are generally considered experimental/investigational unless explicitly covered in policy.

Definition — ExAblate systems (FDA-cleared MRgFUS devices and indications)

Technique summaryExAblate systems are MRgFUS devices that integrate a focused ultrasound transducer with clinical MRI to perform thermoablative treatments under image guidance.

FDA indications (examples)FDA-cleared ExAblate indications include uterine fibroid ablation, palliation of pain from metastatic bone lesions, and ExAblate Neuro for medication‑refractory essential tremor (and tremor‑dominant PD per regulatory summary).

Device componentsSystems include a patient table/cradle housing the ultrasound transducer (water or light oil bath); some cradle types are specific to certain indications (e.g., bone palliation).

Definition — MRgFUS (thermoablative procedure brief)

Procedure briefMRgFUS is a thermoablative procedure that heats targeted tissue in small volume increments under continuous MRI guidance to cause coagulation necrosis.

Treatment deliveryMultiple sonications are directed at the focal point, each producing a rapid local temperature rise to ablate tissue while MRI thermometry monitors effects.

Intended effectCreates focal coagulation necrosis to ablate target tissue and spare adjacent normal structures.

Definition — Responder definition (RCT): NRS responder definition and MEDD context

Responder definition (bone metastasis RCT)Responder defined as ≥2‑point reduction in worst NRS pain score and ≤25% increase in morphine‑equivalent daily dose (MEDD) from baseline to 3 months.

Outcome componentsPrimary composite outcome combined change in worst NRS and change in MEDD; NRS and MEDD were also reported separately as secondary outcomes.

Use in authorizationDocumentation of baseline NRS and MEDD and follow‑up measurements supports assessment of treatment response as defined in trials.

Definition — MRgFUS (thermoablative/MRI guidance duplicate)

Alternate phrasingMRgFUS: a thermoablative MRI‑guided procedure that heats targeted tissue in small volumes using focused ultrasound under continuous MR thermometry.

Clinical monitoringMRI guidance provides both spatial targeting and real‑time thermometric feedback to confirm therapeutic temperatures at the focal point.

ApplicationsUsed for applications such as uterine fibroid ablation, bone metastasis pain palliation, and intracranial thalamotomy for tremor.

Definition — Medication-refractory essential tremor (failure of ≥2 adequate meds)

Medication‑refractory ETMedication‑refractory essential tremor is defined as tremor that has not responded to at least two adequate medical therapies; RCTs required failure of ≥2 medications for enrollment.

Trial eligibilityET RCTs enrolled patients with moderate/severe hand tremor (≥2 on Clinical Rating Scale for Tremor) who were refractory to ≥2 medications.

Authorization implicationPrior authorization for MRgFUS thalamotomy should document trials of ≥2 adequate medications and baseline tremor severity scores.

Definition — MRgFUS (alternate phrasing)

Alternate MRgFUS phrasingMagnetic resonance‑guided focused ultrasound (MRgFUS): noninvasive focused ultrasound ablation performed with MRI guidance and thermometry to heat targeted tissue in small volumes.

EmphasisHighlights MRI‑based targeting and thermometric monitoring as integral to safe and effective focused ultrasound ablation.

Contrast with other modalitiesNoninvasive alternative to percutaneous ablative techniques for selected indications, with unique MR thermometry capability.

Definition — medication-refractory tremor explanatory phrase

Explanatory phraseMedication‑refractory tremor refers to tremor persisting despite trials of appropriate medical therapy; pivotal studies required failure of ≥2 medications before MRgFUS.

Clinical measurementRCTs used validated tremor scales (CRST hand tremor subscore) to quantify severity and response after MRgFUS thalamotomy.

Policy relevanceDocumentation of prior medication trials and validated tremor scores is recommended for coverage consideration.

Definition — MRgFUS duplicate definition entry

Duplicate concise definitionMRgFUS: image‑guided high‑intensity focused ultrasound ablation using MRI for targeting and thermometry to produce focal coagulation necrosis.

Procedure notePerformed as repeated sonications to the focal point with MRI monitoring of temperature and target alignment.

Device compatibilityRequires ultrasound equipment designed to be compatible with MRI scanners and an integrated patient table/cradle for the transducer.

Definition — MRI-guided focused ultrasound thalamotomy (NICE commentary)

NICE commentaryNICE IPG617 states MRgFUS thalamotomy for treatment‑resistant essential tremor raises no major safety concerns but has limited quantity of efficacy evidence; should be used only with special arrangements for governance, consent, audit, or research.

Practical implicationConsider special governance or research arrangements and thorough consent when offering MRgFUS thalamotomy for ET.

Guidance roleNICE recommendation supports cautious use and data collection for intracranial MRgFUS thalamotomy.

Definition — MRgFUS full phrase including stereotactic navigation and frame placement when performed

Full phraseMagnetic resonance‑guided focused ultrasound (MRgFUS): image‑guided high‑intensity focused ultrasound ablation procedure, including stereotactic navigation and frame placement when performed.

Coding noteCPT descriptors for intracranial MRgFUS include language specifying stereotactic navigation and frame placement when performed.

Clinical scopeEncompasses extracranial applications (uterine fibroids, bone metastasis) and intracranial thalamotomy procedures when indicated.

Prior Authorization

Prior authorization recommended for non‑ET uses and ET without refractory documentation

Prior authorization is recommended for all non‑ET indications and for ET cases lacking documentation of medication‑refractory status (failure of ≥2 medications).

Prior Authorization

Prior authorization must document failed ≥2 meds and baseline tremor scores for ET

For ET prior authorization, include documentation of medication‑refractory status (failed ≥2 medications) and baseline validated tremor scores as required by the evidence base.

Provide prior medication list with durations and reasons for failure.
Include baseline CRST or equivalent validated tremor score.

Documentation Required

Document governance/consent and alternative therapy discussion per NICE/ACOG notes

NICE recommends special governance, consent, audit, or research arrangements for MRgFUS thalamotomy; ACOG notes comparative outcome concerns for fibroids — include governance/consent details and alternative discussions in prior‑auth materials where applicable.

Prior Authorization

Check payer systems for prior authorization requirements per CPT code

Verify payer systems for specific prior authorization requirements tied to CPT codes listed in this policy before submission.

Annual review completed and policy renewed (September 2023).

2023-01Annual review / Policy revised

January 2023 annual review and policy revision recorded (January 2023).

2022-01Annual review / Policy renewed

Annual review completed and policy renewed (January 2022).

2021-01Annual review / Policy renewed

Annual review completed and policy renewed (January 2021).

2020-01Annual review / Policy renewed

Annual review completed and policy renewed (January 2020).

2019-01Annual review / Policy revised

January 2019 annual review and policy revision recorded (January 2019).

2018-01Annual review / Policy revised

Annual review and policy revision completed (January 2018).

2017-01Annual review / Policy renewed

Annual review completed and policy renewed (January 2017).

2016-01Annual review / Policy revised

Annual review and policy revision completed (January 2016).

2015-02Annual review / Policy revised

Annual review and policy revision completed (February 2015).

2014-03Annual review / Policy revised

Annual review and policy revision completed (March 2014).

2013-05Annual review / Policy renewed

Annual review completed and policy renewed (May 2013).

2012-05Annual review / Policy renewed

Annual review completed and policy renewed (May 2012).

2011-08Annual review / Policy renewed

Annual review completed and policy renewed (August 2011).